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Drug Res (Stuttg) 2016; 66(07): 371-376
DOI: 10.1055/s-0042-108852
Original Article
© Georg Thieme Verlag KG Stuttgart · New York

Efficacy and Safety of Salmeterol/fluticasone Combination Therapy in Infants and Preschool Children with Asthma Insufficiently Controlled by Inhaled Corticosteroids

S. Yoshihara
1   Department of Pediatrics, Dokkyo Medical University, Tochigi, Japan
,
H. Fukuda
1   Department of Pediatrics, Dokkyo Medical University, Tochigi, Japan
,
M. Tamura
1   Department of Pediatrics, Dokkyo Medical University, Tochigi, Japan
,
O. Arisaka
1   Department of Pediatrics, Dokkyo Medical University, Tochigi, Japan
,
M. Ikeda
2   Department of Pediatric Acute Medicine, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences, Okayama, Japan
,
N. Fukuda
3   Grimm Pediatrics and Allergy Clinic, Tochigi, Japan
,
T. Tsuji
4   Department of Pediatrics, JA Hiroshima General Hospital, Hiroshima, Japan
,
S. Hasegawa
5   Department of Pediatrics, Yamaguchi University Graduate School of Medicine, Yamaguchi, Japan
,
N. Kanno
6   Department of Pediatrics, Nishikata Hospital, Tochigi, Japan
,
M. Teraoka
7   Department of Pediatrics, Kurashiki Municipal Hospital, Okayama, Japan
,
H. Wakiguchi
5   Department of Pediatrics, Yamaguchi University Graduate School of Medicine, Yamaguchi, Japan
,
Y. Aoki
8   Department of Pediatrics, Nagato General Hospital, Yamaguchi, Japan
,
H. Igarashi
9   Department of Pediatrics, Nogi Hospital, Tochigi, Japan
,
A. Terada
10   Terada Kid’s Allergy & Asthma Clinic, Aichi, Japan
,
M. Hasegawa
11   Department of Pediatrics, Yamaguchi Grand Medical Center, Yamaguchi, Japan
,
A. Manki
12   Department of Pediatrics, Okayama City Hospital, Okayama, Japan
› Author Affiliations
Further Information

Publication History

received 13 February 2016

accepted 09 May 2016

Publication Date:
06 June 2016 (online)

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Abstract

Background: Clinical evidences of inhaled salmeterol/fluticasone propionate combination (SFC) therapy are insufficient in early childhood asthma.

Objectives: To examine the effects of SFC50, a combination product of salmeterol xinafoate (50 μg/day) and fluticasone propionate (100 μg/day), in infants and preschool children with asthma.

Methods: The study was conducted at 31 sites in Japan. 35 patients (6 months to 5 years old) with asthma insufficiently controlled by inhaled corticosteroids (100 μg/day) were initiated to treat with SFC50 twice a day for 12 weeks with pressurized metered dose inhalers. The efficacy of SFC50 was assessed using nighttime sleep disorder score as the primary endpoint and the other efficacy measurements. The safety measurement included the incidences of adverse event (AE).

Results: Mean patient age was 3.1 years, and 94.2% had mild-to-moderate persistent asthma (atopic type: 65.7%). Nighttime sleep disorder scores, assessed by a nighttime sleep diary, significantly decreased after treatment with SFC50 throughout the study period (p<0.01). SFC50 also significantly improved other efficacy outcomes including asthma symptom score, frequency of short-acting beta-agonist treatment, frequency of unscheduled visits to clinic, frequency of exacerbation due to virus infection, asthma control score and patient QOL score (p<0.01). AEs of cold, upper respiratory inflammation and asthmatic attack occurred in each of the 3 patients (8.6%); however, these were not regarded as treatment-related AEs.

Conclusions: SFC50 improved nighttime sleep disorder score and other efficacy outcome measures with no safety concerns. The results suggest that SFC50 treatment is useful to control the mild-to-moderate asthma in infant and preschool-aged children.

Key words

salmeterol/fluticasone combination - asthma - infant - preschool children - nighttime sleep disorder score - long-acting beta-agonist - inhaled corticosteroid
 

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